BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COTTON-HUIBREGTSE BILIARY STENT SET

    MDR report key: 15199197 · Received August 10, 2022

    Report

    Report Number
    3001845648-2022-00514
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    December 17, 2015
    Report Date
    October 14, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE DEVICE OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE ¿OFF LABEL USE¿. ADDITIONAL COMPLAINT FILES (B)(4) WAS OPENED AS A RESULT OF THIS PAPER. FILE RELATED TO (B)(4). (3001845648-2022-00512). LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU & LABEL REVIEW: THERE IS EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU0045-7) STATES THE FOLLOWING: ¿INTENDED USE: THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS¿. IT ALSO STATES: ¿NOTES: DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE¿ IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE OF OFF-LABEL USE WAS CONCLUDED BASED ON THE AVAILABLE INFORMATION. THE INTENDED USE IN THE IFU STATES ¿THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS¿ HOWEVER, FROM THE INFORMATION PROVIDED IN THE JOURNAL THE STENTS WERE USED TO AID IN BILIARY DUCT STONE REMOVAL. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE COMPLAINT FILE, NO ADVERSE EVENTS/PATIENT IMPACT WERE REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    YE ET AL 2016 - EFFECTIVENESS AND SAFETY OF BILIARY STENTING IN THE MANAGEMENT OF DIFFICULT COMMON BILE DUCT STONES IN ELDERLY PATIENTS. ENDOSCOPIC SPHINCTEROTOMY WAS PERFORMED IN PATIENTS WITH BILE DUCT ENLARGEMENT, AND SINGLE (8.5 FRENCH (FR); GROUP A) OR DOUBLE (7 OR 8.5 FR; GROUP B) PLASTIC STENTS (WILSON COOK MEDICAL INC.; WINSTON-SALEM, NC, USA) WERE THEN INSERTED INTO THE BILE DUCT OVER A GUIDEWIRE VIA A STANDARD TECHNIQUE, WITH THE PROXIMAL END ABOVE THE STONE AND THE DISTAL END OF THE DUODENUM. IN TOTAL, 34 (53.13%) PATIENTS UNDERWENT SINGLE STENT PLACEMENT AND WERE INCLUDED IN GROUP A. GROUP B INCLUDED 30 (46.88%) PATIENTS WHO UNDERWENT DOUBLE STENT PLACEMENT. COOK STENT WAS USED IN AID OF BILE DUCT STONES REMOVAL IN THIS STUDY IN 64 PATIENTS (94 STENTS), WHICH WAS OFF-LABEL USE. THIS COMPLAINT WAS OPENED TO CAPTURE OFF LABEL USE WITH NO PATIENT IMPACT (82 STENTS). NO ADVERSE EFFECTS REPORTED.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439595 COTTON-HUIBREGTSE BILIARY STENT SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male